FDA approves Genzyme Corp.’s pill for treating multiple sclerosis
Federal regulators Wednesday night gave Genzyme Corp. the go-ahead to sell a new pill to treat multiple sclerosis in the United States.
The positive ruling for the Cambridge biotechnology company’s therapy, called Aubagio, marks the Food and Drug Administration’s first approval of a Genzyme drug since French pharmaceutical giant Sanofi SA bought Genzyme for $20.1 billion in 2010.
Under its new corporate parent, Genzyme, long known as a maker of treatments for rare diseases, has mounted an effort to enter the lucrative, and broader, market for multiple sclerosis drugs, which is estimated at about $13 billion a year worldwide.
Most multiple sclerosis drugs now available are given to patients through injections. The autoimmune disease affects the brain and central nervous system of about 400,000 Americans and 2.5 million people globally. Among the treatments are Avonex, made by Weston-based Biogen Idec Inc., and Rebif, manufactured by German-owned EMD Serono of Rockland.
Aubagio “offers patients an opportunity to remove themselves from the burden of daily or weekly injections,” said Bill Sibold, head of Genzyme’s multiple sclerosis business.
Last month, Genzyme suffered a setback when the FDA asked it to change the way it presents clinical data and resubmit an application it filed in June for approval of Lemtrada, another late-stage multiple sclerosis drug candidate Genzyme had hoped to start selling early next year.
Lemtrada, which is aimed at patients with more severe cases of multiple sclerosis, is administered intravenously once a year for five days the first year of use, and for three days the next year.
“We see the two drugs as being complementary, covering the span of MS patients,” Sibold said. While Genzyme had been developing Lemtrada before its acquisition, Aubagio came out of the Sanofi pipeline and was placed under the Genzyme umbrella after the takeover.
Over the past year, since the Sanofi multiple sclerosis programs were consolidated at Genzyme, the company’s Cambridge-based multiple sclerosis workforce has quadrupled to nearly 300.
Sanofi has been paring its research and development operations in Europe, moving some programs to the United States, and stepping up collaborations with smaller biotechs and academic researchers. The company considers the multiple sclerosis field as a potential growth area. But it faces stiff competition in that market from a range of established players, including Biogen Idec and Switzerland’s Novartis AG, which already sells the oral drug Gilenia for MS.
Wednesday’s approval marks the third time in recent weeks that Massachusetts life sciences companies were given the FDA’s green light for potentially important products.
Ironwood Pharmaceuticals Inc. of Cambridge last month won approval to market its new drug to treat irritable bowel syndrome with constipation. And earlier this week, the FDA cleared Danvers cardiac device maker Abiomed Inc. to sell a new model of its heart pump.
Investors bid up Sanofi shares Wednesday in anticipation of the FDA action. The stock price climbed 8 cents, or 0.2 percent, to $43.26 on the New York Stock Exchange.Robert Weisman can be reached at firstname.lastname@example.org.